Donor screening test to detect HBsAg. Also for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and intesting blood specimens to screen cadaveric (non-heart-beating) donors.

Abbott LaboratoriesAbbott Park, ILUS License 0043

7/18/2006

Anti-HIV-1 Oral Specimen Collection Device

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

OraSure HIV-1 Oral Specimen Collection Device

Oral Specimen Collection Device

Oral Fluid

For Use with HIV diagnostic assays that have been approved for use with this device.

Donor screening test for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens. Also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors.

For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. Also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating.

To be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating.

Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors. Also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating

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